FEATURED EDITORIAL

GUEST CONTRIBUTORS

  • Developing Control Strategies For Gene Therapy Products — What Role Should CMOs Play?
    Developing Control Strategies For Gene Therapy Products — What Role Should CMOs Play?

    The explosion of gene therapy candidates in clinical development is being led by a diverse set of originators, including many hospital and university labs. While these are great incubators for innovation, the many small labs working in isolation do not have experience in commercializing a medicine for wide and sustained use in patients, and this could slow the acceptance of gene therapies for the people who really need them. Health authorities have recognized the importance of getting gene therapies into standard use and are supporting doing so with accelerated pathways.

  • Improving Training In Biopharmaceutical Manufacturing
    Improving Training In Biopharmaceutical Manufacturing

    Whether improvements in the delivery of training in biopharmaceutical manufacturing are needed is an open question, and the answers are not clear-cut. BioPlan recently conducted independent research to address this question.

  • 5 Strategies To Combat Counterfeit Drugs And Pharma Supply Chain Threats
    5 Strategies To Combat Counterfeit Drugs And Pharma Supply Chain Threats

    Pharma companies ignore the issue of counterfeiting and drug diversion at their own peril. This article discusses noteworthy examples of how drug manufacturers of various sizes are tackling this problem.

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PHARMA OUTSOURCING WHITE PAPERS

Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins

This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

Overview Of A Scale-Up Of A Cell-Based Influenza Virus Production Process Using Single-Use Bioprocessing Equipment Overview Of A Scale-Up Of A Cell-Based Influenza Virus Production Process Using Single-Use Bioprocessing Equipment

This paper includes a discussion on vaccine processes, followed by a case study on the scale-up of upstream and downstream processes for the production of a cell-based live attenuated influenza virus using single-use ReadyToProcess technology.

Drug Safety And Product Protection Driving Blister Packaging Growth

Trends in packaging of prescription and over-the-counter drugs indicate continued growth in the blister packaging market. 

The Future Of BioManufacturing

The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using single-use technology.

Pharma Production Tech Transfers: Reaping Rewards, Reducing Risks

Transferring production — and the technologies that undergird it — can be risky. The same product can behave differently in different equipment, resulting in low yields or even batch rejections.

Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins

This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

To The Rescue – Getting A Phase I Oncology Study Back On Track

A small, oncology-focused biotech was experiencing significant data, safety, vendor and monitoring issues in its Phase I programs that were worsening with time.

Beyond EDC: Resolving Data-Entry Challenges Faced By Electronic Data Capture Systems In Clinical Trials

Electronic Data Capture (EDC) systems have swept the Clinical Trials industry in recent years, promising to transform the drug development process.

Does Your Pharma CMO Deliver On Its Promises After Being Acquired?

I first met Mark Bamforth, the president and CEO of Gallus BioPharmaceuticals, at a conference shortly after he had acquired/founded his CMO in St. Louis. The company was so new many of the employees at the event didn’t even have business cards.

What Do Consultants Look For When Advising Drug Development Companies On CRO Selection?

L.E.K., founded in 1983, is a global strategy consulting firm with offices across Europe, the Americas, and Asia-Pacific. One of its more than 900 employees, Jonathan Kfoury, functions as the VP of L.E.K.’s Boston office, with a focus on R&D, partnership, and commercialization strategy development for biopharmaceutical and medical technology companies. By Rob Wright

More Pharma Outsourcing App Notes & Case Studies

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Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

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About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

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OUTSOURCING EVENTS

24th Annual Validation Week October 22 - 24, 2018
San Diego, CA)
IRT 2018 October 22 - 23, 2018
Philadelphia, PA)
eCOA/ePRO 2018 October 23, 2018
Philadelphia, PA)
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